Tresiba® Reduces Hypoglycaemia Regardless of Blood Sugar Level

Abu Dhabi, Uae (ots/PRNewswire) -

People with either type 1 or type 2 diabetes treated with Tresiba®
had fewer episodes of low blood sugar (hypoglycaemia) compared with
people on insulin glargine U100 regardless of whether they had
achieved blood sugar targets.[1] These new post-hoc analyses from the
SWITCH 1 and 2 trials were presented at the International Diabetes
Federation (IDF) Annual Congress in Abu Dhabi today.[2],[3]

"Achieving target blood sugar levels can be a constant challenge
for people with diabetes treated with insulin, and this is made even
more complex by the risk of hypoglycaemia," said Mads Krogsgaard
Thomsen, executive vice president and chief science officer at Novo
Nordisk. "Tresiba® has consistently been shown to provide stable
blood sugar control while at the same time reducing hypoglycaemia
compared with insulin glargine U100; it is very encouraging to see
that treatment with Tresiba® helps people to achieve blood sugar
control with fewer episodes of hypoglycaemia regardless of their
blood sugar levels in this analysis."

The findings of these analyses are consistent with the results of
the main SWITCH trials which demonstrated significantly lower rates
of overall symptomatic hypoglycaemia versus insulin glargine U100 in
people with type 1 and type 2 diabetes.[2],[3]

About hypoglycaemia

Hypoglycaemia occurs when blood sugar levels are too low and
cannot provide the body's organs with the energy they need.
Hypoglycaemia can cause a range of symptoms including confusion,
trembling, sweating, increased heart rate, difficulty with
concentration and/or speech and in severe cases can lead to a seizure
or coma.[4]-[6] Severe hypoglycaemia can cause extensive damage to
the body and is significantly associated with cardiovascular
death.[7] Every month, 46.5% of people with type 2 diabetes and 83.0%
of people with type 1 diabetes experience a hypoglycaemic episode.[8]

About the new analyses

The analyses, based on the recent SWITCH trials, separated people
into two groups depending on whether they had achieved target blood
sugar levels (defined as HbA1c of 7.0% or less) during the
maintenance period of the trial.[1] Target blood sugar levels are
those recommended by the joint guidelines of the American Diabetes
Association and the European Association for the Study of
Diabetes.[9]

About SWITCH 1 and 2

SWITCH 1 and SWITCH 2 were two phase 3b, 64-week, double-blind,
randomised, treat-to-target, 2-period crossover trials that
investigated the hypoglycaemia profile of Tresiba® compared with
insulin glargine U100 in people with type 1 and type 2 diabetes,
respectively. The trial design included a titration period in which
the doses of study treatments (Tresiba® or insulin degludec U100)
were gradually increased over a 16 week period, followed by a 16 week
maintenance period during which a constant dose of study treatment
was maintained.[2],[3] The primary endpoint was the number of severe
or blood glucose-confirmed symptomatic hypoglycaemic episodes
observed in participants during the maintenance period.[2],[3]

About Tresiba®

Tresiba® (insulin degludec) is a once-daily basal insulin that
provides a duration of action beyond 42 hours with a flat and stable
glucose-lowering effect.[10],[11] It has been shown to provide a
lower risk of overall, nocturnal and severe hypoglycaemia, and low
variability in blood glucose levels versus insulin glargine
U100.[11],[12] Tresiba® received its first regulatory approval in
September 2012 and has since been approved in more than 80 countries
globally. It is now commercially available in more than 50 countries.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 41,700 people in 77 countries and markets its
products in more than 165 countries. For more information, visit
novonordisk.com (https://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.youtube.com/novonordisk)

Further information

Media:

Katrine Sperling +45 4442 6718 krsp@novonordisk.com

Åsa Josefsson +45 3079 7708 aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com

Hanna Ögren +45 3079 8519 haoe@novonordisk.com

Anders Mikkelsen +45 3079 4461 armk@novonordisk.com

Christina Kjær +45 3079 3009 cnje@novonordisk.com

Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

References

1. Gumprecht J, Lane W, Chaykin LB, et al. Lower rate of
hypoglycaemia with insulin degludec vs. insulin glargine U100 after
adjusting for HbA1c in SWITCH 1 and 2. Poster presentation.
International Diabetes Federation (IDF) Annual Congress 2017, Abu
Dhabi, UAE. December 2017.

2. Lane W, Bailey TS, Gerety G, et al. Effect of insulin
degludec vs insulin glargine U100 on hypoglycemia in patients with
type 1 diabetes: The SWITCH 1 randomized clinical trial. JAMA.
2017;318:33-44.

3. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin
degludec vs insulin glargine U100 on hypoglycemia in patients with
type 2 diabetes: The SWITCH 2 randomized clinical trial. JAMA.
2017;318:45-56.

4. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and
diabetes: a report of a workgroup of the American Diabetes
Association and the Endocrine Society. Diabetes Care.
2013;36:1384-1395.

5. International Hypoglycaemia Study Group. Diagnosis of
hypoglycaemia. Available online at
http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last
accessed November 2017.

6. Cryer P. Hypoglycemia, functional brain failure, and brain
death. Journal of Clinical Investigation. 2007;117:868-870.

7. Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal
relationships between severe hypoglycaemia, cardiovascular outcomes
and mortality. Diabetologia. 2017.

8. Khunti K, Alsifri S, Aronson R, et al. Rates and predictors
of hypoglycaemia in 27 585 people from 24 countries with
insulin-treated type 1 and type 2 diabetes: the global HAT study.
Diabetes Obes Metab. 2016;18:907-915.

9. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of
Hyperglycemia in Type 2 Diabetes, 2015: A Patient Centered Approach.
Diabetes Care 2015;38:140-149.

10. Haahr H, Heise T. A review of the pharmacological
properties of insulin degludec and their clinical relevance. Clin
Pharmacokinet. 2014;53:787-800.

11. EMA. Tresiba® Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/002498/WC500138940.pdf. Last accessed: November
2017.

12. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety
of degludec versus glargine in type 2 diabetes. N Engl J Med.
2017;377:723-732.

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de

Original-Content von: Novo Nordisk A/S, übermittelt durch news aktuell